Similarly, people with secondary-progressive MS, which is generally considered a later stage of relapsing-remitting MS, are no doubt eager for treatments to slow or halt the disease progression that they typically experience after relapses mostly or completely stop. Good news: The wait for new options may be getting shorter. Researchers in Britain announced on Monday that by fall 2021, they plan to begin recruiting participants for the world’s first clinical trial designed to assess whether drugs already on the market can help slow MS progression and, perhaps, reverse some of the disability caused by the condition.
Octopus Trial Designed to Evaluate Drugs Quickly
Indeed, the so-called Octopus trial — the name comes from the multiple treatment “arms,” or groups receiving different drugs — will enable researchers to investigate the potential benefits of several medications simultaneously, with the goal of identifying safe and effective new treatments three times faster than if the options were studied separately, according to the MS Society in Britain, which is funding the trial as part of its “Stop MS” campaign. “I know research progress can feel frustratingly slow, but this is a major milestone,” writes the MS Society’s assistant director of research, Emma Gray, PhD, in a blog post. “After years of planning, our ambition to speed up clinical trials for progressive MS is going to become a reality. And by 2025 we hope to be in the late stages of testing treatments to slow or stop progression for everyone with MS.” Unlike relapsing-remitting forms of MS, PPMS causes a steady, gradual change in functional ability — particularly with walking — over time, according to the National MS Society in the United States. As a result, the disease-modifying therapies used for relapsing forms of MS — which include clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS — don’t work as well for PPMS, as they are designed to reduce central nervous system inflammation, rather than reverse nerve degeneration, the National MS Society says.
Drugs With Neuroprotective and Remyelinating Effects to Be Tested
The drugs that will be evaluated in the Octopus trial have not yet been selected. However, the project will focus on currently available therapies that have already been shown to provide “neuroprotective and remyelinating” benefits in other conditions, explains Jeffrey Cohen, MD, director of the experimental therapeutics program at the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research in Ohio. These are drugs that are essentially designed to repair and rebuild the central nervous system, effectively bolstering its cells, structure, and function. Examples of existing drugs with possible neuroprotective benefits include the statins lovastatin and fluvastatin, which are used to manage high cholesterol, as well as beta-blockers such as metoprolol, and COX-2 selective inhibitors such as celecoxib, which are used in the treatment of high blood pressure, according to a review published in December 2018 in the Journal of Pharmacopuncture.
Trial Design Allows Researchers to Focus on Drug Efficacy
However, there’s no indication that these will necessarily be among the drugs included in the Octopus trial, which will be structured to allow for testing of multiple drugs at once and comparing findings to a single control group, Dr. Gray writes. Researchers will use magnetic resonance imaging (MRI) scans to evaluate the effects of the drugs on disability progression. Drugs that look promising will “stay in the trial … so what would normally be two consecutive trials are delivered in one,” Gray explains. The trial “will focus on repurposed medications, ones that have already been tested or approved for other indications, which expedites testing by allowing initial safety … studies to be skipped,” adds Dr. Cohen, who will not be involved in the Britain-based project led by researchers at University College London. “If a treatment is identified with meaningful … activity and good safety and tolerability, that potentially would have important clinical significance,” for people with PPMS, he adds.
